Table 2.

Treatment efficacy

Neratinib monotherapy
ResponseER+ERNeratinib + fulvestrant
All patients (intent to treat)a(n = 23)(n = 11)(n = 47)
Confirmed overall objective response,b n (%)4 (17.4)4 (36.4)14 (29.8)
 Complete response2 (8.7)1 (9.1)4 (8.5)
 Partial response2 (8.7)3 (27.3)10 (21.3)
 Overall objective response rate (95% CI)17.4 (5.0–38.8)36.4 (10.9–69.2)29.8 (17.3–44.9)
CBR,c % (95% CI)30.4 (13.2–52.9)36.4 (10.9–69.2)46.8 (32.1–61.9)
Time to event (months), median (95% CI)
 PFS3.6 (1.8–4.3)2.0 (1–5.5)5.4 (3.7–9.2)
 DOR6.5 (3.7–NA)3.8 (3.7–NA)9.2 (5.5–16.6)
RECIST-measurable disease only(n = 18)(n = 10)(n = 39)
Confirmed overall objective response, bn (%)3 (16.7)2 (20.0)12 (30.8)
 Complete response1 (5.6)1 (10.0)2 (5.1)
 Partial response2 (11.1)1 (10.0)10 (25.6)
 Overall objective response rate, % (95% CI)16.7 (3.6–41.4)20.0 (2.5–55.6)30.8 (17.0–47.6)
CBR,c % (95% CI)27.8 (9.7–53.5)20.0 (2.5–55.6)46.2 (30.1–62.8)
Time to event (months), median (95% CI)
 PFS3.6 (1.8–4.3)1.9 (1.0–5.4)5.4 (3.5–10.3)
 DOR7.4 (3.7–NA)3.8 (3.7–3.9)9.0 (4.5–16.6)
  • Abbreviations: CBR, clinical benefit rate; NA, not available.

  • aResponse is based on investigator-assessment per RECIST (version 1.1), in patients with measurable disease, or PET response criteria in patients without measurable disease.

  • bConfirmed no less than 4 weeks after the criteria for response are initially met.

  • cClinical benefit is defined as confirmed best overall response of complete response, partial response of any duration, or stable disease lasting for at least 24 weeks.